in force 2024-07-09 MODIFIED+545 −112§
Amended by Regulation (EU) 2024/1860 32024R1860
applies from: unknown (the text changed beyond its dates, so no date that moved can be read as the application date)
dates removed: 2027-05-25, 2027-05-26
Paragraph 14 no longer sets fixed calendar dates of 25 May 2027 and 26 May 2027 for when all Member States must apply the coordinated assessment procedure.
Instead, the obligation for all Member States to apply the procedure is now tied to a date calculated as five years from publication of the notice referred to in Article 34(3) confirming that the electronic system is functional, with an interim period before that date, starting at the earliest six months after that same notice, during which only Member States that have agreed to apply the procedure do so.
Cited: Art. 78, v1 · Art. 78, v2
text before / after
02017R0745-20230320 → 02017R0745-20240709
Article 78
Coordinated assessment procedure for clinical investigations
1. By means of the electronic system referred to in Article 73, the sponsor of a clinical investigation to be conducted in more than one Member State may submit, for the purpose of Article … 1,166 unchanged words … 4.2, 4.3 and 4.4 of Chapter II of Annex XV, which shall be assessed separately by each Member State concerned.
13. The Commission shall provide administrative support to the coordinating Member State in the accomplishment of its tasks under this Chapter.
14. The All Member States shall be required to apply the procedure set out in this Article shall, until 25 May 2027, from the date corresponding to 5 years from the date of publication of the notice referred to in Article 34(3), informing that the electronic system referred to in Article 33(2), point (e), is functional and meets the functional specifications drawn up pursuant to Article 34(1).
Before the date set out in the first subparagraph of this paragraph and at the earliest 6 months from the date of publication of the notice referred to in that subparagraph, the procedure set out in this Article shall be applied only by those of the Member States in which the clinical investigation is to be conducted which have agreed to apply it. From 26 May 2027, all Member States shall be required to apply that procedure.